Patient -Ventilator Interaction in Chronic Respiratory Failure

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Clinical Trial to Optimise Patient-ventilator Interaction in Patients With Chronic Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371149
• Other study ID #: 10/H0716/67
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2011
• Last updated: April 2, 2014
• Start date: January 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Patients over the age of 16 years.

2. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.

3. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning.

4. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day.

5. No prior domiciliary ventilation.

Exclusion Criteria:

1. Patients with other co-morbidities e.g. cancer or cardiac failure.

2. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.

3. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.

4. Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100).

5. Patients with a psychological, social or geographical situation that would impair compliance with the project.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hypercapnic Respiratory Failure
• Chronic Obstructive Pulmonary Disease
• Hypoventilation
• Lung Diseases, Obstructive
• Neuromuscular Disease
• Neuromuscular Diseases
• Obesity Hypoventilation Syndrome
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Other:
• Surface parasternal electromyography (EMG) set up
Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.

Locations

Country	Name	City	State
United Kingdom	Guy's and St. Thomas' NHS Trust	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Michelle Ramsay	Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence with ventilation	Data on patient reported compliance and ventilator recorded compliance will be collected.	3 months	No
Secondary	health related quality of life	SRI, RAND-36, visual analogue scores, St. George's respiratory questionnaire	3 month	No
Secondary	length of hospital stay for initiation of home mechanical ventilation		3 months	No
Secondary	gas exchange	overnight oximetry, overnight capnography,arterial oxygenation, arterial carbon dioxide	3 months	Yes